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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, oximeter, fiberoptic
Regulation Description Fiberoptic oximeter catheter.
Product CodeDQE
Regulation Number 870.1230
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 5
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 21
Difficult to insert 21
Measurements, inaccurate 19
Deflation issue 18
Material frayed 14
No code available 14
Incorrect or inadequate result 13
Difficult to remove 12
Foreign material present in device 10
No Known Device Problem 10
Unraveled material 9
Other (for use when an appropriate device code cannot be identified) 9
Contamination during use 9
Fluid leak 8
Break 8
Inflation issue 7
Material rupture 7
Unknown (for use when the device problem is not known) 7
Incorrect measurement 6
Difficult to advance 5
Low readings 5
Cut in material 4
Unable to obtain readings 4
Tip breakage 3
High Readings 3
Device damaged prior to use 3
Positioning Issue 3
Material perforation 2
Stretched 2
Connection issue 2
Output issue 2
Sterility 2
Kinked 2
Knotted 2
Difficult to position 2
Air leak 2
Balloon rupture 2
Bent 1
Detachment of device component 1
Disconnection 1
Erratic display 1
Melted 1
Failure to pace or properly pace 1
Foreign material 1
Fracture 1
Accuracy rate 1
Shelf life exceeded 1
Source, detachment from 1
Sticking 1
Tubing, incorrect placement of 1
Twisting 1
Uncoiled 1
Detachment of device or device component 1
Tears, rips, holes in device, device material 1
Use of Device Issue 1
Defective component 1
Failure to calibrate 1
Unintended movement 1
Total Device Problems 293

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